Friendship Based HIV/STI (Sexually Transmitted Infections) Intervention for African American Females
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ClinicalTrials.gov Identifier: NCT00109421 |
Recruitment Status
:
Completed
First Posted
: April 28, 2005
Last Update Posted
: February 28, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sexual Behavior Sexually Transmitted Diseases HIV Infections | Behavioral: Project ÒRÉ | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 420 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | PROJECT ÒRÉ: An Innovative Friendship Based HIV/STI Intervention for High Risk African American Females |
Study Start Date : | November 2004 |
Actual Primary Completion Date : | November 2009 |
Actual Study Completion Date : | November 2009 |
Arm | Intervention/treatment |
---|---|
Experimental: Experimental arm
In the experimental condition, the intervention group will receive the half-day Project ÒRÉ intervention. All participants will complete pre-, post- and 3-month follow-up self-administered questionnaires. A subset of groups will participate in a process evaluation focus group immediately following the program.
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Behavioral: Project ÒRÉ
Community-based adolescent social network HIV/STI intervention tailored to African American culture
Other Name: ÒRÉ
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No Intervention: Attention control group
The attention control group will receive a standard health promotion control program which has been used previously with similar populations. All participants will complete pre-, post- and 3-month follow-up self-administered questionnaires.
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- Conduct elicitation research in the study community [ Time Frame: 18 Months ]To conduct elicitation research in the study community to: assess the applicability of the existing Project ÒRÉ intervention modules, modify the intervention for the specific populations that are targeted in the current study, and incorporate local data in the production of three brief videos involving youth in the study community
- Test the efficacy of the intervention [ Time Frame: 18 Months ]To use a group-randomized controlled design to conduct a test of the efficacy of the Project ÒRÉ intervention.
- Conduct a qualitative process evaluation [ Time Frame: 18 Months ]To conduct a qualitative process evaluation to assess the acceptability of the experimental intervention in a new community using a subset of the participants in the experimental condition.

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Ages Eligible for Study: | 14 Years to 21 Years (Child, Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Female
- Between the ages of 14-18
- Self-identifies as African American
- Sexually experienced
- Willing to participate in a single five-hour workshop and a one-hour follow-up session
- Willing to nominate 2-5 close female friends ages 14-21 to participate in the study with her
- Lives in the experimental intervention community
- Ability to obtain permission from parent or legal guardian and assent from minors or consent from those above age of majority
Exclusion Criteria:
- Individual reports predominantly same gender sexual behavior
- Recent homelessness
- Visibly distraught or unstable (i.e. suicidal, manic, exhibiting violent behavior, etc.)
- Intoxicated or under the influence of psychoactive agents

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00109421
United States, California | |
University of California, San Francisco | |
San Francisco, California, United States, 94143 |
Principal Investigator: | M. Margaret Dolcini, Ph.D. | University of California, San Francisco |
Responsible Party: | University of North Carolina, Chapel Hill |
ClinicalTrials.gov Identifier: | NCT00109421 History of Changes |
Other Study ID Numbers: |
ATN 034 |
First Posted: | April 28, 2005 Key Record Dates |
Last Update Posted: | February 28, 2017 |
Last Verified: | February 2016 |
Keywords provided by University of North Carolina, Chapel Hill:
adolescent female community-based |
social network HIV/STI intervention High HIV-risk African American adolescent females |
Additional relevant MeSH terms:
Infection HIV Infections Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections |
Virus Diseases Sexually Transmitted Diseases, Viral Immunologic Deficiency Syndromes Immune System Diseases Genital Diseases, Male Genital Diseases, Female |